Sample collection

ABSTRACT

Sample collection apparatus and methods of sample collection are provided, for example saliva collection apparatus and methods of saliva collection. Said apparatus conveniently comprises a filter assembly and an interface for delivering material from the apparatus to an assay unit.

FIELD OF THE INVENTION

The present invention relates to sample collection apparatus and methodsof sample collection, for example saliva collection apparatus andmethods of saliva collection.

The present invention relates to filter assemblies, and to methods offiltering, for example to filter assemblies and methods of filteringsuitable for use in filtering collected samples of saliva.

The present invention relates to a sample collection apparatuscomprising an interface for delivering material from the apparatus to anassay unit, and to methods using the same.

BACKGROUND TO THE INVENTION

Collecting a sample of oral fluid, for example a sample of saliva froman individual is typically performed by having the individual drool intoa specimen container or blow a sample down a straw into a genericspecimen container.

The dimensions of typical specimen containers are generally not suitedto collection of drool, for example by providing a only narrow openingto receive the sample, and/or by comprising features which makeinterfacing with the body of the individual providing the sample moredifficult, such as a circular opening with a thread for retaining a lidon the container after the sample has been delivered. Larger specimencontainers with large size openings into which drooling may take placeare available, but the distribution of a sample, which may only be ofsmall volume, across the interior surface of a larger specimen containercan make it difficult to determine whether a sufficient amount of droolhas been provided.

The straw technique is also not particularly easy to perform, requiringcoordination of straw and sample container, and typically alsointroducing unwanted bubbles into the sample.

Example embodiments of the present invention aim to address at least onedisadvantage associated with the prior art apparatus and methods,whether identified herein or otherwise, e.g. in aiding the collection ofa sample of saliva by drooling.

In performing medical analysis on a sample, for example a sample ofsaliva, there must be sufficient material in the sample to enable theanalysis to be performed. Samples of saliva generally comprise of aliquid element with suspended particulates therein, and it is desirableto separate the liquid element from the particulates for delivery to ananalyser. This is so that the particulates do not interfere with theanalysis by contamination of sensors, impeding flow through or contactwith the sensor assemblies etc. Centrifugation and/or filtrationtechniques can be used to perform separation of liquid fromparticulates. Centrifugation is expensive and the equipment forperforming centrifugation is not generally transportable, meaning thatit is unsuitable for point-of-care testing, near the patient or by thepatient themself. Effective filtration may take a relatively long timeto perform. With both techniques there are issues when working with onlya small amount of material in a sample, so that wastage or loss ofmaterial is to be reduced.

Example embodiments of the present invention aim to address at least onedisadvantage associated with the prior art apparatus and methods,whether identified herein or otherwise, e.g. in aiding the separation ofa sample of saliva through use of a filter assembly.

A sample of saliva, once collected in a suitable specimen container, isnormally transferred into a further vessel for delivery to assayequipment. The amount of material required by the assay equipment may berelatively small, but it is important that the sample is notcontaminated during collection or transfer and that if there is only asmall amount of sample available that loss of sample material isavoided.

Example embodiments of the present invention aim to address at least onedisadvantage associated with the prior art apparatus and methods,whether identified herein or otherwise, e.g. in aiding the collection ofa sample and its proper delivery to an assay unit without undue delay,loss or contamination.

SUMMARY OF INVENTION

According to the present invention there is provided a sample collectionapparatus and a method of sample collection, for example a salivacollection apparatus and a method of saliva collection. Other, optional,features of the invention will be apparent from the dependent claims,and the description which follows.

There now follows a summary of various aspects and advantages accordingto embodiments of the invention. This summary is provided as anintroduction to assist those skilled in the art to more rapidlyassimilate the detailed discussion herein and does not and is notintended in any way to limit the scope of the claims that are appendedhereto.

In one example there is provided a sample collection apparatuscomprising an open ended container to receive a sample, andcharacterised by a projecting surface that extends generally outwardlyand upwardly from the open end of the container to form an ergonomic lipengaging portion.

In this document, the term lip is used to encompass both the lip itself,and also the region of the body below the lip between the lip and thechin. Hence an ergonomic lip engaging portion is in use to engage thisarea of the body.

In one example the lip engaging portion is arranged to aiding thecollection of a sample of saliva by drooling.

In one example the open end comprises a first portion from which theprojecting surface extends, and a second portion from which it does notextend, such that the second portion is generally inward of projectingsurface and generally there-below.

In one example the projecting surface provides a contact region of thelip engaging portion, arranged in use to contact the body of a user. Inone example the projecting surface provides a contact region of the lipengaging portion, arranged in use to contact the body of a user, thecontact region comprising a non convex outer edge. In one example theprojecting surface provides a contact region of the lip engagingportion, arranged in use to contact the body of a user, the contactregion comprising a straight, or a concave outer edge. In one examplethe projecting surface provides a contact region of the lip engagingportion, arranged in use to contact the body of a user, the contactregion comprising a concave outer edge, when viewed from above. In oneexample the projecting surface provides a contact region of the lipengaging portion, arranged in use to contact the body of a user, thecontact region comprising a concave outer edge, when viewed downwardly,i.e. in a direction into the open end of the container.

In one example the projecting surface provides a funnelling region ofthe lip engaging portion, arranged in use to funnel sample materialdownward, toward the open end of the container. In one example thefunnelling region is provided as a dip in the projecting surface. In oneexample the funnelling region is provided as a channel in the projectingsurface. In one example the funnelling region is provided between wingsangled at the sides of the projecting surface. In one example thefunnelling region is provided between wings angled upward at the sidesof the projecting surface.

In one example the centre of the contact region is aligned with thecentre of the funnelling region. In one example the concavity of thecontact region transitions into the funnelling region of the lipengaging portion such that material passed onto the projecting surfaceat the contact region is funnelled there-from by the funnelling region.

In one example the contact region is symmetrical about a median plane ofthe sample collection apparatus. In one example the funnelling region issymmetrical about a median plane of the sample collection apparatus.

In one example embodiment the projecting surface is symmetrical about amedian plane of the sample collection apparatus. In one exampleembodiment the projecting surface is symmetrical about a median plane ofthe sample collection apparatus, such that the median plane of thesample collection apparatus is arrangeable in use to contact the body ofa user in alignment with a median plane of the body of the user.

In one example embodiment the projecting surface comprises a roll-topedge. In one example embodiment the roll-top edge terminates with adownward sloping extremity, for example a downward slope at one or moreof: the first portion, the second portion, the contact region, thefunnelling region, and the wings. In one example embodiment the roll-topedge terminates with an outward slope, for example an outward slope atone or more of: the first portion, the second portion, the contactregion, the funnelling region, and the wings.

In one example embodiment the projecting surface comprises a saddlepoint. In one example embodiment the projecting surface comprises asaddle point at a convexity of the roll-top edge and a concavity of thefunnelling region. In one example embodiment the saddle point isprovided on a median line of the projecting surface.

In one example embodiment the projecting surface extends from the openend, said open end being generally circular when viewed from above.

In one example the projecting surface comprises a low-friction surface,such as a polished area, or a coating, to inhibit adhesion of samplematerial thereto. In one example the projecting surface comprises aplastics material. In one example the projecting surface comprises anextension of a wall of the container, for example an outer wall of thecontainer. In one example the projecting surface comprises an extensionof a cylindrical wall of the container.

In one example the sample collection apparatus comprising an open endedcontainer to receive a sample from a user, by the user drooling onto theprojecting surface while the lip engaging portion is against the body,for example lip, of the user.

In one example the sample collection apparatus comprising an open endedcontainer to receive a sample from a user, by the user drooling onto theprojecting surface while the lip engaging portion is against the lip ofthe user, or against the body of the user between the lip and chin ofthe user.

In one example there is provided a method of sample collection using asample collection apparatus comprising an open ended container toreceive a sample from a user, the method comprising:

arranging a projecting surface, that extends generally outwardly andupwardly from the open end of the container to form an ergonomic lipengaging portion, against the body of the user at or below the lip ofthe user; and

collecting drool from the user, into the container, from the projectingsurface.

In one example the method of sample collection is performed using asample collection apparatus substantially as described in the examplesherein.

In one example the method comprises arranging a contact region of thelip engaging portion in contact with the body of a user.

In one example the method comprises arranging a median plane of thesample collection apparatus to contact the body of a user in alignmentwith a median plane of the body of the user.

In one example the method comprises arranging an open ended container toreceive a sample from a user, by the user drooling onto the projectingsurface while the lip engaging portion is against the body of the user.

In one example the method comprises arranging an open ended container toreceive a sample from a user, by the user drooling onto the projectingsurface while the lip engaging portion is against the lip of the user,or against the body of the user between the lip and chin of the user.

In one example there is provided a filter assembly for use in filteringsamples of saliva, the filter assembly comprising a first filter elementarranged to separate relatively large particulate matter from a sample,by action of gravity drawing the relatively smaller particulate matterand liquid components through the first filter element, characterised inthat the first filter element comprises an upwardly angled first filtersurface, arranged with a wall, to pool the sample in a corner regionbetween the first filter surface and the wall.

In one example the first filter surface is provided as part of anupwardly extending first filter element. In one example the area on thefirst filter surface provided by the first filter element is ofgenerally reducing cross section going from the bottom of the firstfilter element toward the top. In one example the upwardly extendingfirst filter element tapers toward the top. In one example the firstfilter surface is provided as part of the first filter element as agenerally conical or generally frustoconical surface.

In one example the filter assembly is provided in a container, such thatwith the container resting on a level surface the first filter surfaceis an upwardly angled first filter surface. In one example the filterassembly comprises an upwardly angled first filter surface which slopesat an angle of 30 degrees to 50 degrees to the vertical, for exampleapproximately 40 degrees. In one example the filter assembly comprises acone angle of 80 degrees to 120 degrees to the vertical, for exampleapproximately 100 degrees.

In one example embodiment the first filter element comprises a pluralityof discrete filter holes. In one example embodiment the first filterelement comprises a plurality of substantially identical filter holes.In one example the holes are generally circular. In one exampleembodiment the first filter element comprises holes of between 0.3 mmand 1.3 mm in diameter, for example between 0.5 mm and 1.1 mm, forexample between 0.7 mm and 0.9 mm. In one example embodiment the firstfilter element comprises holes of 0.8 mm in diameter. In one exampleembodiment the holes are arranged in a plurality of generally concentriccircular groups. In one example embodiment the holes are defined bypassageways of between 1 mm and 4 mm in length, for example between 2 mmand 3 mm in length, for example 2.88 mm in length. In one example theratio of characteristic axial dimension of the passageways to crosssectional dimension is in the region of 3:1 to 4:1, for example 3.6:1.In one example the holes present an opening having an edge which is notaligned with the horizontal, for example an edge which is not alignedwith the axial dimension of the passageways. In one example the holespresent an opening which comprises an edge which is angled so as to begenerally parallel to the first filter surface.

In one example the first filter surface comprises an array of 50 to 150holes, for example 100 to 140 holes, such as 123 holes. In one example ahole, for example each of the holes in a plurality of holes, comprisesbetween 0.1% and 0.2% of the area of the first filter surface. In oneexample the first filter element comprises holes that make up between 5%and 30% of the first filter surface, for example between 10% and 20%,such as 16%.

In one example the first filter surface comprises a first group of holesarranged relatively closer to the corner, and a second group of holesarranged relatively further from the corner. In one example the firstgroup of holes comprises a relatively smaller number of holes than thesecond group of holes. In one example the first filter surface comprisesa plurality of groups of holes, for example, two, three or more, withthe groups of holes arranged relatively further from the corner regionin sequence. In one example the number of holes in a group of holesfurther from the corner region is fewer than the number of holes in agroup relatively closer to the corner. In one example the groups ofholes are arranged in a circular pattern, or are grouped into a numberof circular patterns. In one example, the holes are arranged with bandsof holes running at generally the same distance from the corner, and thebands having more holes per band as the bands approach the corner.

In one example the first filter element is provided as an insertarranged in a container in which the sample is provided. In one examplethe first filter element and container are arranged, such that insertingthe first filter element into the container to an inserted positioncauses retention of the first filter element in the container. In oneexample the first filter element and container are arranged, such thatpushing the first filter element into the container to an insertedposition causes retention of the first filter element in the container.In one example the first filter element and container are arranged, suchthat inserting the first filter element into the container to aninserted position causes retention of the first filter element in thecontainer. In one example the first filter element and container arearranged, such that inserting the first filter element into thecontainer to an inserted position causes retention of the first filterelement in the container. In one example the first filter elementcomprises a friction fit, or interference fit with the container.

In one example the wall is provided, at least in part, by an opposedportion of the first filter element, providing an upwardly angledsurface that extends from the corner region away from the first filtersurface.

In one example the wall is provided, at least in part, by a container inwhich the sample has been collected. In one example the containercomprises a wall with which the first filter element can be arranged toprovide the corner region between the first filter surface and the wall,at least in part. Part of the corner region may be provided by theopposed portion of the first filter element, in one instance a lowerpart of the corner region. Part of the corner region may be provided bythe wall, in one instance an upper part of the corner region.

In one example the wall is a non-filtering wall. In one example the wallis that of the container, and defines a generally cylindrical interiorsurface in the region of the first filter element. In one example thewall is provided such that with the container resting on a level surfacethe wall extends generally upwards vertically.

In one example the corner region comprises an angle of between 70degrees and 110 degrees, for example approximately 90 degrees. In oneexample the corner region comprises an angle, for example of less than170 degrees, or less than 150 degrees, such as for example less than 130degrees, or less than 110 degrees. In one example the corner regionprovides an angle of greater than 10 degrees, for example greater than30 degrees, or greater than 50 degrees, or greater than 70 degrees.

In one example the filter assembly comprises a second filter element. Inone example embodiment the first and second filter elements are arrangedin the filter assembly such that the output side of the first filterelement is in fluid communication with the input side of the secondfilter element. In one example embodiment the second filter element isarranged to separate relatively small particulate matter from a sample,by action of gravity drawing the liquid component through the secondfilter element such that only particulate matter below a predeterminedthreshold remains with the filtered liquid component. In one exampleembodiment the second filter element comprises a smaller cross sectionalarea than the first filter element.

In one example the filter assembly is arranged with a buffer volumebetween the output side of the first filter element and the input sideof the second filter element, such that material that passes through thefirst filter element can accumulate and/or be held in the buffer volume,for example when the rate of passage of material through the firstfilter element is greater than the rate of passage of material throughthe second filter element.

In one example the second filter element is made of a porous material.In one example embodiment the second filter element comprises anarrangement of wadding, or of fibres. In one example the wadding, orfibres are made of a material that is itself non-porous.

In one example embodiment the second filter element is located below thefirst filter element in the container. In one example embodiment thesecond filter element is provided as an insert arranged in a containerin which the sample is provided.

In one example the first filter element, second filter element andcontainer are arranged, such that inserting the first filter elementinto the container to an inserted position causes retention of thesecond filter element in the container. In one example the second filterelement and container are arranged, such that inserting the secondfilter element into the container to an inserted position causesretention of the second filter element in the container. In one examplethe second filter element comprises a friction fit, or interference fitwith the container.

In one example embodiment the filter assembly is arranged such that thefirst filter element contacts the second filter element, to hold thesecond filter element in place in the filter assembly. In one exampleembodiment the first filter element comprises a leg extending down belowthe first filter surface arranged to contact the second filter elementand to hold the second filter element in place.

In one example there is provided a method of filtering, the methodperformed using a filter assembly for filtering samples of saliva, andcomprising a first filter element arranged to separate relatively largeparticulate matter from a sample, by action of gravity drawing therelatively smaller particulate matter and liquid components through thefirst filter element, the method comprising collecting a sample ofsaliva, and characterised by pooling the collected sample in a cornerregion between an upwardly angled first filter surface of the firstfilter element and a wall.

In one example the method of filtering is performed using a samplecollection apparatus substantially as described in the examples herein.

In one example the method of filtering comprises a collection pre-stepof sample collection substantially as described in the examples herein.

In one example there is provided a sample collection apparatuscomprising a collection space for accumulating a sample, an assay unitand an interface between the collection space and the assay unit;characterised in that the interface is arranged to transform from aclosed configuration in which the collection space is isolated from theassay unit to an open configuration in which a sample accumulated in thecollection space is delivered to the assay unit.

In one example the collection space and assay unit are arranged relativeto one another such that delivery of a sample to the assay unit may takeplace under the influence of gravity.

In one example the assay unit comprises a region of low pressure, forexample a partial vacuum. In one example the assay unit comprises aregion of pressure lower than atmospheric pressure. In one example theinterface is arranged such that transformation from the closedconfiguration to the open configuration exposes the low pressure regionof the assay unit to the collection space. In one example the interfaceis arranged such that transformation from the closed configuration tothe open configuration exposes a low pressure region of the assay unitto the collection space, such that contents of the collection space areforcibly delivered to the assay unit.

In one example the collection space comprises an outlet passageway andthe assay unit comprises an inlet passageway, and the interface isarranged such that transforming from the closed configuration to theopen configuration comprises bringing the passageways from an unalignedposition to an aligned position.

In one example the collection space and assay container are providedwith a seal there-between. In one example the collection space and assaycontainer each interface a sealing element, for example each interface acommon sealing element, to isolate one from the other in the closedconfiguration. In one example the collection space and assay containerare provided with a seal there-between to isolate the fluid connectionby which a sample is delivered from the collection space to the assayunit from a mechanical connection provided to couple the assaycollection space and the assay container.

In one example the collection space and assay unit comprise a mechanicalconnection by which they are coupled to one another to allow relativerotation. In one example the collection space and assay unit arearranged such that relative rotation there-between transforms theirinterface from the closed configuration to the open configuration.

In one example the mechanical connection is provided as a snap fit orinterference fit. In one example the mechanical connection is providedbetween a projection and a recess, arranged one on the collection spaceand the other on the assay container. In one example the collectionspace and assay unit are demountably coupled one another to separate byelastic deformation of the snap fit or interference fit mechanicalconnection.

In one example the collection space comprises a ventilation opening bywhich air from within the collection space may vent. In one example thecollection space comprises a ventilation opening which is open to theatmosphere. In one example the collection space comprises a plurality ofsaid ventilation openings.

In one example collection space and assay unit comprise a mechanicalconnection by which they may be coupled to one another, and furtherarranged such that effecting mechanical connection of the collectionspace and assay unit provides a ventilation blocking member to block theventilation opening. In one example the sample collector comprises aplurality of ventilation openings. In one example the sample collectorcomprises a ventilation blocking member for each of ventilation openingin a plurality of ventilation openings, such as for all ventilationopenings. In one example the assay unit comprises the ventilationblocking member(s).

In one example the mechanical connection is arranged such that slidingof the projection in the interface transforms the interface from theclosed configuration to the open configuration. In one example themechanical connection is arranged such that sliding of the projection inthe interface in a first direction transforms the interface from theclosed configuration to the open configuration, and that sliding in asecond direction transforms the interface from the open configuration tothe closed configuration. In one example the first direction and seconddirection are opposite in sense to each other, for example opposite inrotational sense such as body rotation without axial displacement, or inopposite parallel directions.

In one example the assay unit comprises a frangible sealing member atthe interface. In one example the collection space comprises a frangiblesealing member at the interface. In one example the interface comprisesa frangible sealing member, associated with one of the collection spaceand assay unit, for example only one of the collection space and theassay unit. In one example the collection space, and/or the assay unitcomprises a piercing member arranged to break open a frangible sealingmember in transformation of the interface from the closed configurationto the open configuration. In one example the piercing member isarranged to push through the frangible sealing member in transformationof the interface from the closed configuration to the openconfiguration. In one example the piercing member and interface arearranged to cooperate with one another such that piercing of a frangiblesealing member occurs as the collection space and assay unit are pushedtogether, for example as the collection space and assay unit are beingmechanically connected to one another.

In one example the mechanical connection is arranged such that continuedsliding of the projection in the interface transforms the interface fromthe closed configuration to the open configuration, and thereaftertransforms the interface back from the open configuration to the closedconfiguration.

In one example the collection space comprises a container of meteredvolume and an overflow container. In one example the collection spacecomprises a plurality of containers of metered volume, for example incombination with a single overflow container. In one example thecollection space comprises a plurality of containers of metered volume,and the assay unit comprises a plurality of assay volumes. In oneexample the metered volumes and assay volumes are provided incorresponding numbers. In one example a metered volume of the collectionspace comprises an outlet passageway and an inlet passageway of theassay unit is provided as part of an assay volume. In one example theinterface is arranged such that transforming from the closedconfiguration to the open configuration comprises bringing the meteredvolumes and assay volumes from an unaligned position to an alignedposition, such that their respective passageways align with one anotherto form a fluid connection there-between.

In one example the interface is arranged such that transformation fromthe closed configuration to the open configuration exposes the lowpressure region of the assay unit to the collection space via alowermost portion of the collection space, such that contents of thelowermost portion are forcibly delivered to the assay unit. In oneexample the interface is arranged such that transformation from theclosed configuration to the open configuration exposes the low pressureregion of the assay unit to the collection space via a lower portion ofthe metered volume, such that contents of the metered volume areforcibly delivered to the assay unit.

In one example the assay unit comprises a transparent material. In oneexample the assay unit comprises a window through which its content maybe viewed or otherwise analysed.

In one example there is provided a sample collection method comprising:

accumulating a sample in a collection space of a sample collectionapparatus;

transforming an interface between the collection space and an assay unitfrom a closed configuration in which the collection space is isolatedfrom the assay unit, to an open configuration; and

delivering the sample accumulated in the collection space to the assayunit.

In one example the method of sample collection is performed using asample collection apparatus substantially as described in the examplesherein.

In one example the collection space comprises an outlet passageway andthe assay unit comprises an inlet passageway, and the method comprisesbringing the passageways from an unaligned position to an alignedposition.

In one example the method comprises transforming the interface betweenthe collection space and assay unit by relative motion there-between,for example by relative rotation of the collection space and assay unit.

In one example the method comprises filling a container of meteredvolume in the collection space with material of the sample, andcollecting further material of the sample in an overflow container. Inone example the method comprises filling a plurality of containers ofmetered volume in the collection space with material of the sample, andcollecting further material of the sample in an overflow container.

In one example the method comprises delivering material of the samplefrom the collection space into one, or into a plurality of assay volumesin the assay unit.

In one example method comprises transforming from the closedconfiguration to the open configuration to bring metered volume(s) andassay volume(s) from an unaligned position to an aligned position, suchthat respective outlet and inlet passageways thereof connect with oneanother.

In one example the method comprises accumulating the sample in thecollection space under gravity.

In one example the method comprises delivering the sample to the assayunit under gravity.

In one example the method comprises pre-loading the assay unit with areagent.

In one example the method comprises the mixing of a sample with areagent in the assay unit.

In one example the method comprises inspecting, or otherwise analysingthe content of the assay unit while the sample is contained therein.

In one example the method comprises using a low pressure region in theassay unit to force the sample from the collection space.

In one example the collection space comprises a ventilation opening, andthe method comprises blocking the ventilation opening. In one examplethe assay unit comprises a ventilation blocking member and the methodcomprises blocking the ventilation opening of the collection unit withthe ventilation blocking member. In one example the method comprisesblocking the ventilation opening as the collection unit and assay unitare moved relative to one another, such as in the process of couplingthe collection space and assay unit to one another.

In one example the method comprises piercing a frangible sealing memberprovided at the interface. In one example the method comprises piercinga frangible sealing member as the collection unit and assay unit aremoved relative to one another, such as in the process of coupling thecollection space and assay unit to one another.

In one example there is provided a sample collection apparatuscomprising two or three of:

(a) an open ended container to receive a sample, and characterised by aprojecting surface that extends generally outwardly and upwardly fromthe open end of the container to form an ergonomic lip engaging portion;

(b) a filter assembly for use in filtering samples of saliva, the filterassembly comprising a first filter element arranged to separaterelatively large particulate matter from a sample, by action of gravitydrawing the relatively smaller particulate matter and liquid componentsthrough the first filter element, characterised in that the first filterelement comprises an upwardly angled first filter surface, arranged witha wall, to pool the sample in a corner region between the first filtersurface and the wall; and

(c) a sample collection apparatus comprising a collection space foraccumulating a sample, an assay unit and an interface between thecollection space and the assay unit; characterised in that the interfaceis arranged to transform from a closed configuration in which thecollection space is isolated from the assay unit to an openconfiguration in which a sample accumulated in the collection space isdelivered to the assay unit.

In the aforementioned apparatus there may be additional features asdescribed in relation the apparatus aspects (a), (b) and (c) in thecorresponding optional statements above.

In one example there is provided a method of sample collectioncomprising two or three of:

(i) using a sample collection apparatus comprising an open endedcontainer to receive a sample from a user, the method comprising:

arranging a projecting surface, that extends generally outwardly andupwardly from the open end of the container to form an ergonomic lipengaging portion, against the body of the user at or below the lip ofthe user; and

collecting drool from the user, into the container, from the projectingsurface;

(ii) using a filter assembly for filtering samples of saliva, andcomprising a first filter element arranged to separate relatively largeparticulate matter from a sample, by action of gravity drawing therelatively smaller particulate matter and liquid components through thefirst filter element, the method comprising collecting a sample ofsaliva, and characterised by pooling the collected sample in a cornerregion between an upwardly angled first filter surface of the firstfilter element and a wall; and;

(iii) accumulating a sample in a collection space of a sample collectionapparatus;

transforming an interface between the collection space and an assay unitfrom a closed configuration in which the collection space is isolatedfrom the assay unit, to an open configuration; and delivering the sampleaccumulated in the collection space to the assay unit.

In the aforementioned method there may be additional steps as describedin relation the aspects (i), (ii) and (iii) in the correspondingoptional statements above.

BRIEF INTRODUCTION TO DRAWINGS

For a better understanding of the invention, and to show how exampleembodiments may be carried into effect, reference will now be made tothe accompanying drawings in which:

FIGS. 1A and 1B are perspective views of an example sample collectionapparatus;

FIG. 2 is a cut-away perspective view of the sample collection apparatusof FIG. 1A and FIG. 1B;

FIGS. 3A, 3B and 3C show detail of a lip engaging portion of the samplecollection apparatus of FIG. 1A and FIG. 1B;

FIGS. 4A and 4B show detail of a first filter element of the samplecollection apparatus of FIG. 1A and FIG. 1B;

FIGS. 5A through 5D show detail of the a collection space and assay unitof another example sample collection apparatus;

FIG. 6 shows a cut-away view of still another example sample collectionapparatus;

FIG. 7 shows a cut-away view of a ventilation closing arrangement ofstill yet another example sample collection apparatus; and

FIGS. 8A, 8B and 8C show example methods of sample collection, filteringand using a sample collection apparatus respectively.

DESCRIPTION OF EXAMPLE EMBODIMENTS

At least some of the following example embodiments provide an improvedsample collection apparatus. Many other advantages and improvements willbe discussed in more detail below, or will be appreciate by the skilledperson from carrying out example embodiments based on the teachingsherein.

FIGS. 1A and 1B show a schematic view of an example sample collectionapparatus 1. The sample collection apparatus 1 comprises an open endedcontainer to receive a sample from the mouth of a user. In a clinicalsituation the user may be a patient and the sample being collected maycomprise saliva to be analysed for clinically relevant characteristics,such as the presence of biomarkers etc. To enable an effective analysisof the sample there are certain requirements around collection of thesample. For example, the collection apparatus should enable a clean,uncontaminated sample to be collected. Once the sample material has beendelivered into a sample collection apparatus it is helpful for thesample to be processed by filtration and prepared for analysis.Delivering a suitable amount of sample material in a timely manner andin a way which is convenient for subsequent analysis is also desirable.

The sample collection apparatus 1 of FIGS. 1A and 1B is intended tofacilitate collection of a sample, and as such comprises a projectingsurface 10 that extends generally outwardly and upwardly from the openend 12 of the container. The projecting surface 10 forms an ergonomiclip engaging portion. The lip engaging portion aids the collection of asample of saliva by drooling.

A user arranges the lip engaging portion against the lower lip, or inthe region just below the lower lip between lip and chin, on the medianplane of the body. By allowing saliva to collect in the mouth, and thendrooling over the lip, the user can provide saliva into the samplecollection apparatus through the open end 12 thereof. This procedure isconvenient, as the upward and outward disposition of the lip engagingportion allows drooling into the sample collection apparatus 1 to takeplace without significant leaning forward of the head of the user. Inone example embodiment the projecting surface comprises a roll-top edge.

The sample collection apparatus 1 is intended to be intuitive to use, inthe sense that by providing the open end 12 with a portion from whichthe projecting surface 10 extends, and a separate portion from which theprojecting surface 10 does not extend, it can be readily understood bythe user where the lip engaging portion is, and where it ought to bepositioned in use. As shown in FIGS. 1A and 1B, the portion of the openend 12 from which the lip engaging portion does not extend is arrangedgenerally inward of projecting surface 10 and generally there-below.

For comfort, and to match the shape of the anatomy of a user theprojecting surface 10 provides a contact region 14 of the lip engagingportion. This contact region 14 in use contacts the body of a user andin the sample collection apparatus 1 comprises a concave outer edge 16when viewed downwardly, i.e. in a direction into the open end of thecontainer. A roll-top edge to the projecting surface 10 terminates witha downward sloping extremity at the contact region, enhancing comfort asthe contact region 14 is in use against the lip.

In order to funnel sample material downward the projecting surfaceprovides a funnelling region of the lip engaging portion toward the openend of the container. The funnelling region is provided as a dip betweenwings 18 that angle upward at the sides of the projecting surface 10.The centre of the contact region 14 is aligned with the centre of thefunnelling region so that the concavity of the contact region 14transitions into the funnelling region of the lip engaging portion suchthat material passed onto the projecting surface at the contact region14 is funnelled there-from by the funnelling region, down toward theopen end 12. To aid funnelling the projecting surface 10 comprises alow-friction finish, and the projecting surface transitions smoothlydown into the open end as a integral part of the wall of the samplecollection apparatus with no step, joining line or similar between thelip engaging portion and the open end 12, or indeed below the open end12.

Below the open end 12 is a filter assembly 20 for use in filteringsamples of saliva. FIG. 2 shows the filter assembly in more detail in acut-away perspective view of the sample collection apparatus of FIG. 1Aand FIG. 1B. The filter assembly 20 comprises a first filter element 21,also visible in FIG. 1A and FIG. 1B. The first filter element 21 isarranged to separate relatively large particulate matter from a sample,by action of gravity drawing the relatively smaller particulate matterand liquid components there-through. The first filter element 21comprises an upwardly angled first filter surface 23, arranged with awall 24. In use the sample being filtered pools in a corner region 25between the first filter surface 23 and the wall 24.

The wall 24 is provided in part, by an opposed portion of the firstfilter element 21, providing an upwardly angled surface that extendsfrom the corner region 25 away from the first filter surface 23, andabove this region is provided by a container 30 in which the sample hasbeen collected. The corner region 25 comprises an angle of approximately90 degrees.

The first filter element 21 tapers toward the top such that the firstfilter surface 23 comprises a generally conical surface. With thecontainer resting on a level surface the first filter surface 23upwardly angled with a cone angle of approximately 40 degrees. The firstfilter element 21 comprises a plurality of discrete filter holes thatare each of 0.8 mm in diameter. The holes are arranged in a plurality ofgenerally concentric circular groups with 123 holes shown in total inthe embodiment of FIGS. 1-4. FIG. 4A and FIG. 4B show the first filterelement 21 in more detail. The holes are at the ends of passageways of2.88 mm in length. In this way, the ratio of the characteristic axialdimension of the passageways to cross sectional dimension is 3.6:1,which has been found to enable efficient filtering of typicalparticulate contaminants in material having the general consistency ofsaliva.

To aid passage of liquid through the holes the holes present an openinghaving an edge which is not aligned with the horizontal, in this caseparallel to the first filter surface. This enables liquid to startpassing down through the hole and into the passageway as it runs downthe first filter surface as it first encounters a hole edge. The wholeof the hole does not need to be wetted, and in fact the angled edge aidsventilation from below the first filter element for periods offiltration where the entirety of the passageway is not occluded withliquid/particles. To further improve transit of the liquid components ofthe saliva through the first filter element 21 while removing typicalparticulate contaminants the holes provide 16% of the area of the firstfilter surface 23.

Pooling in the corner region 25 enables a relatively small amount ofsample material to accumulate to a greater depth, thereby increasing thetendency of the liquid to pass through the holes by gravity. The cornerregion 25 is also the region where a relatively large number of theholes are disposed, since the holes are provided in groups of holes eacharranged relatively further from the corner and at a higher point on thefirst filter surface. 23. However, to maintain good filter throughputwhen a large volume of sample material is present, or when the holes inthe corner region are obstructed by larger particles that cannot passthere-through, the first filter element 23 angles upwardly away from thewall, to enable a greater volume of sample material to be exposed to thefirst filter surface 23.

As can be appreciated from FIGS. 1-4, the first filter element 23 isprovided as an insert arranged in a container 30 in which the sample isto be provided. The first filter element 21 is provided as push-fit inthe container to, to retain the first filter element 21 in the container30 and as explained in more detail below to contact a second filterelement 22 and to thereby also retain the second filter element 22 inthe container 30. The second filter element 22 is also provided as aninsert in the container 30. The first filter element 21 comprises a leg26 extending down below the first filter surface 23 and arranged incontact with the second filter element 22 and to hold the second filterelement in place.

The second filter element 22 is provided in the sample collectionapparatus 1 to work with the first filter element 21 as part of thefilter assembly 20. The output side of the first filter element 21 is influid communication with the input side of the second filter element 22.Following removal of relatively larger particulate from the sample bythe first filter element 21 the second filter element 22 is arranged toseparate out relatively smaller particulates from a sample by action ofgravity drawing the liquid component through the second filter element22. The second filter element 22 comprises a plug of fibrous waddingmaterial.

Only particulate matter below a predetermined threshold remains with thefiltered liquid component in the output of the second filter element 22,which also comprises the output of the filter assembly 20. Material thatpasses through the first filter element 21 can accumulate and be held ina buffer volume between the first filter element 21 and the secondfilter element 22 when the rate of passage of material through the firstfilter element 21 is greater than the rate of passage of materialthrough the second filter element 22. As can be appreciated from theFIGS. 2 and 3C, the second filter element 22 comprises a smaller crosssectional area than the first filter element 21, but a greater verticaldepth. Reduction of the cross sectional area in this way provides anincreased depth of liquid in a buffer volume between the output side ofthe first filter element 21 and the input side of the second filterelement 23. Thus the narrow cross section of the buffer volume serves toincrease passage of material through the second filter element 23.

The output of the filter assembly is provided from the second filterelement to accumulate in a collection space there-below. Theaccumulation of sample material in the collection space may then bedelivered to an assay unit as described in more detail below withreference to FIGS. 2, 5 and 6. In the embodiments described above thecollection space 40 is provided with one or more ventilation openings 32by which air from within the collection space may vent. In the exampleshown in FIGS. 1-3 three ventilation openings 32 are provided around thecontainer 30 at 120 degree separation from each another. The ventilationopenings 32 are provided so that air from within the collection space 40can exit the container, making space for the sample to pass into thecollection space 40.

The sample collection apparatus shown comprises an interface 50 betweenthe collection space 40 and the assay unit 60. The interface 50 isarranged to transform from a closed configuration in which thecollection space 40 is isolated from the assay unit 60 to an openconfiguration in which a sample accumulated in the collection space 40is delivered to the assay unit 60. The assay unit 60 may be providedwith an assay solution or reagent that is used to evaluate theconstituents or other characteristics of the sample, such as by a colourchange reaction which is visible through a transparent wall portion ofthe assay unit. Maintaining the reagent separate from the sample, byproviding the interface 50 ensures that the correct reaction can takeplace between the sample and the reagent, and that the reaction takesplace at a time where its outcome can be observed.

The collection space 40 and assay unit 60 are arranged relative to oneanother such that delivery of the sample to the assay unit 60 takesplace under the influence of gravity. The base of the assay unit 60enables the sample collection apparatus to stand on a flat surface andfor the filtering and delivery of the sample to take place without theneed for centrifugation.

To assist in delivery of the sample to the assay unit 60 the assay unitis provided as a closed volume, for example comprising a reagent and aregion of low pressure. A partial vacuum can be used such that thecontents of the assay unit 60 are kept at lower than atmosphericpressure. In this way, transformation of the interface 50 from theclosed configuration to the open configuration exposes the low pressureregion of the assay unit 60 to the collection space 40. The low pressurethen acts with the atmosphere so contents of the collection space 40,including at least part of the sample, are forcibly delivered to theassay unit 60. It is desirable, as explained below, that the lowpressure region of the assay unit 60 is connected to a portion of thecollection space such that the sample fills the connection passagewayand that therefore the sample is delivered into the low pressure regionrather than air bypassing the sample.

As shown in FIGS. 5A through 5D, the collection space 40 comprises threecontainers of metered volume 42 and an overflow container 44. The assayunit comprises a plurality of assay volumes 62 corresponding to themetered volumes 42 of the collection space 40. The metered volumes 42each comprise an outlet passageway the assay volumes 62 each comprise aninlet passageway. Transforming the interface 50 from the closedconfiguration to the open configuration comprises bringing the meteredvolumes and assay volumes from an unaligned position to an alignedposition, such that their respective passageways connect with oneanother, by relative rotation of the collection space 40 and the assayunit 60. A relative rotation in the reverse sense takes the passagewaysback to the unaligned positions so that the collection space and assayunit are again isolated from one another at the interface, therebypreventing any further sample material having an effect on the contentof the assay unit.

The transformation of the interface as described exposes the lowpressure region of the assay unit 60 to the collection space 40 via alowermost portion of the collection space 40, such that contents of thelowermost portion are forcibly delivered to the assay unit 60. In factthe contents of the metered volumes 42 are forcibly delivered to theassay unit since the outlet passageways of the metered volumes comprisethe lowermost portion of the collection space from which sample materialcan be delivered to the assay unit 60.

In use the metered volumes are arranged to fill with sample materialdelivered from the second filter element 22, and then overflow into theoverflow container 44. This means that a full metered volume 42 deliversno more than the volume thereof to the assay unit 60. In correspondingmanner the assay volumes 62 may be pre-loaded with a measured amount ofreagent to react with the sample material delivered thereto from themetered volumes 42, for example with different reagents in differentassay volumes 62, or the same reagent provided more than once to give acontrol or supplementary check.

In the embodiments shown the collection space 40 and assay container 60are provided with a seal 52 at the interface 50 there-between. The seal52 works with a mechanical connection 54 by which the collection space40 and assay container 60 are coupled to one another. The seal 52 isprovided as a gasket with holes therein, by which the passageways mayconnect, for example a gasket formed of a plastics material or a naturalor synthetic rubber material.

FIG. 6 shows an example embodiment in which a frangible sealing memberhas been provided as the interface 50. The frangible sealing member (notshown) is provided on the collection space 40 and serves to close thebottom of the collection space 40. The assay unit 50 comprises apiercing member 54 arranged to break open a frangible sealing member inthe process of transformation of the interface from the closedconfiguration to the open configuration. The piercing member 56 isarranged to push through the frangible sealing member as the collectionspace 40 and assay unit 60 are pushed together to mechanically connectone to the other. In the embodiment of FIG. 6, it is clear how thepushing together of the assay unit 60 and collection space 40 forms amechanical connection by a recess 66 on an interior wall of the assayunit 60 cooperating with a projection 46 extending from an exterior wallof the container 30 in the region of the collection space 40. In anotherembodiment the interface 50 further comprises a frangible sealing member(not shown) provided on the assay unit 60 to close the top of the assayunit 60. In such embodiments the interface may is for example providedby the two frangible sealing members, with the end region of thecollection space breaking the frangible sealing member on the assay unit60 as the end region of the collection space enters the assay unit 60,and a piercing member associated with the assay unit 60 breaking thefrangible sealing member on the collection space also as the end regionof the collection space. As will be appreciated, a piercing member maybe provided in the collection space, and the transformation of theinterface by breaking of frangible sealing members may take place withthe features of assay unit and collection space at the interfacereversed from the embodiments described above. It will be understoodthat frangible sealing members used in these embodiments are preferablymade from a material which can be pierced, or otherwise breached withoutdisintegrating into fragments, so as to avoid contamination of thesample. Polymeric films, laminated foils etc. are suitable, and may beprovided with inbuilt lines of weakness such as by scoring in order tofacilitate operations as described above.

FIG. 7A and FIG. 7B show an example embodiment in which the container 30that provides the collection space 40 and assay unit 60 comprise amechanical connection by which they may be coupled to one another, saidmechanical connection including providing a ventilation blocking members64 on the assay unit 60 to block ventilation openings 32. Blocking theventilation openings once the mechanical connection has been madebetween the collection space 40 and the assay unit 60 is useful for tworeasons. Firstly, it prevents sample material from leaking out of theventilation openings 32 if the sample collector is knocked over orotherwise tipped onto its side. Secondly, in embodiments where the assayunit 60 is at lower than atmospheric pressure, it prevents air fromentering the ventilation openings as the region of reduced pressure inthe assay unit 60 is exposed to the collection space 40 ontransformation of the interface 50. This means that there is more chanceof sample material being transferred into the assay unit 60 from thecollection space, and/or means that sample material in the filterassembly is drawn through to the collection space for delivery to theassay unit 60.

FIG. 8A shows an example method of sample collection using a samplecollection apparatus comprising an open ended container to receive asample from a user. At S110, a projecting surface that extends generallyoutwardly and upwardly from the open end of the container to form anergonomic lip engaging portion is arranged against the body of the userat or below the lip of the user. At S120, drool from the user iscollected into the container, from the projecting surface. Step S110 maybe understood to further include the step of arranging a contact regionof the lip engaging portion in contact with the body of a user inalignment with a median plane of the body of the user.

FIG. 8B shows an example method of sample filtering using a filterassembly for filtering samples of saliva, and comprising a first filterelement arranged to separate relatively large particulate matter from asample, by action of gravity drawing the relatively smaller particulatematter and liquid components through the first filter element. At S210,a sample of saliva is collected by pooling of the collected sample in acorner region between an upwardly angled first filter surface of thefirst filter element and a wall. At S220, the relatively largeparticulate matter is separated from a sample, by action of gravitydrawing the relatively smaller particulate matter and liquid componentsthrough the first filter element.

S210 may be preceded by steps S110 and S120 described in relation toFIG. 8A.

FIG. 8C shows an example method of using a sample collection apparatus.At S310, a sample is accumulated in a collection space of a samplecollection apparatus. At S320, an interface between the collection spaceand an assay unit is transformed from a closed configuration in whichthe collection space is isolated from the assay unit, to an openconfiguration. At S330, the sample accumulated in the collection spaceis delivered to the assay unit.

Where the collection space comprises an outlet passageway and the assayunit comprises an inlet passageway, S320 may be expanded to include thestep of bringing the passageways from an unaligned position to analigned position in transforming the interface between the collectionspace and assay unit by relative motion there-between, for example byrelative rotation of the collection space and assay unit.

S330 may be expanded to include the step of filling a container ofmetered volume in the collection space with material of the sample, andcollecting further material of the sample in an overflow container sothat delivering material of the sample from the collection space takesplace into one, or into a plurality of assay volumes in the assay unit.

S310 may be preceded by the step of pre-loading the assay unit with areagent.

S330 may be followed by the step of mixing of a sample with a reagent inthe assay unit, and thereafter inspecting the content of the assay unitwhile the sample is contained therein.

As set out above, the sample collection apparatus aims to provide aconvenient way for a saliva sample to be received. It will be understandthat the saliva sample as discussed may contain entrained sputum orother material delivered from the mouth of the user so as not to becomprised completely of material produced by the salivary glands.However, this does not impact on the use or general efficacy of theembodiments. The sample collection can be in a clinical setting, underguidance from a healthcare professional, or, as will be appreciated themethod of use is simple enough to be undertaken without supervision yeta good quality sample and assay output can still be achieved. The riskof spillage is reduced, as is wastage of saliva in wetting surfaces andfilter components. The collected sample is filtered effectively, and canbe delivered in a proper clean and timely manner to an assay unit foranalysis without the need for centrifugation, and without the risk ofcontamination or spillage.

In addition to the advantages and improvements in each functionalunit/operational process of collecting a sample, it will be appreciatedthat the functional units/operational processes work together to enablethe end-to-end collection and processing of a sample in a single device.

Although the example embodiments have been described with reference tothe components, modules and units discussed herein, such functionalelements may be combined into fewer elements or separated intoadditional elements. Various combinations of optional features have beendescribed herein, and it will be appreciated that described features maybe combined in any suitable combination. In particular, the features ofany one example embodiment may be combined with features of any otherembodiment, as appropriate, except where such combinations are mutuallyexclusive. Throughout this specification, the term “comprising” or“comprises” may mean including the component(s) specified but is notintended to exclude the presence of other components.

Although a few example embodiments have been shown and described, itwill be appreciated by those skilled in the art that various changes andmodifications might be made without departing from the scope of theinvention, as defined in the appended claims.

Attention is directed to all papers and documents which are filedconcurrently with or previous to this specification in connection withthis application and which are open to public inspection with thisspecification, and the contents of all such papers and documents areincorporated herein by reference.

All of the features disclosed in this specification (including anyaccompanying claims, abstract and drawings), and/or all of the steps ofany method or process so disclosed, may be combined in any combination,except combinations where at least some of such features and/or stepsare mutually exclusive.

Each feature disclosed in this specification (including any accompanyingclaims, abstract and drawings) may be replaced by alternative featuresserving the same, equivalent or similar purpose, unless expressly statedotherwise. Thus, unless expressly stated otherwise, each featuredisclosed is one example only of a generic series of equivalent orsimilar features.

The invention is not restricted to the details of the foregoingembodiment(s). The invention extends to any novel one, or any novelcombination, of the features disclosed in this specification (includingany accompanying claims, abstract and drawings), or to any novel one, orany novel combination, of the steps of any method or process sodisclosed.

We claim:
 1. A sample collection apparatus comprising a filter assemblyto filter samples of saliva collected therein, the filter assemblycomprising: a first filter element arranged to separate relatively largeparticulate matter from a sample, by action of gravity drawing therelatively smaller particulate matter and liquid components through thefirst filter element, the first filter element comprises an upwardlyangled conical or frustoconical first filter surface, arranged with awall, to pool the sample in a corner region between the first filtersurface and the wall; wherein the filter assembly comprises a secondfilter element; and wherein the first and second filter elements arearranged in the filter assembly such that the output side of the firstfilter element is in fluid communication with the input side of thesecond filter element, and wherein the second filter element is arrangedto separate relatively small particulate matter from a sample, by actionof gravity drawing the liquid component through the second filterelement such that only particulate matter below a predeterminedthreshold remains with the filtered liquid component.
 2. The filterassembly according to claim 1, wherein the filter assembly is arrangedwith a buffer volume between the output side of the first filter elementand the input side of the second filter element.
 3. The filter assemblyaccording to claim 1, wherein the first filter surface is provided aspart of an upwardly extending first filter element.
 4. The filterassembly according to claim 1, wherein the first filter elementcomprises a plurality of discrete filter holes.
 5. The filter assemblyaccording to claim 1, wherein the first filter surface comprises a firstgroup of holes arranged relatively closer to the corner, and a secondgroup of holes arranged relatively further from the corner.
 6. Thefilter assembly according to claim 1, wherein the first filter elementis provided as an insert arranged in a container in which the sample isprovided.
 7. The filter assembly according to claim 1, wherein the firstfilter element and the container are arranged, such that inserting thefirst filter element into the container to an inserted position causesretention of the first filter element in the container.
 8. The filterassembly according to claim 1, wherein the wall is provided, at least inpart, by an opposed portion of the first filter element, providing anupwardly angled surface that extends from the corner region away fromthe first filter surface.
 9. The filter assembly according to claim 1,wherein the wall is provided, at least in part, by the container inwhich the sample has been collected.
 10. The filter assembly accordingto claim 1, wherein the second filter element is made of a fibrousmaterial.
 11. The filter assembly according to claim 1, wherein thesecond filter element is provided as an insert arranged in a containerin which the sample is provided.
 12. The filter assembly according toclaim 1, wherein the first filter element, second filter element andcontainer are arranged, such that inserting the first filter elementinto the container to an inserted position causes retention of thesecond filter element in the container.
 13. A method of filtering salivain a sample collection apparatus, the method performed using a filterassembly of the sample collection apparatus comprising a first filterelement arranged to separate relatively large particulate matter from asample, by action of gravity drawing the relatively smaller particulatematter and liquid components through the first filter element, and asecond filter element arranged such that the output side of the firstfilter element is in fluid communication with the input side of thesecond filter element and the second filter element is arranged toseparate relatively small particulate matter from the sample, by actionof gravity drawing the liquid component through the second filterelement such that such that only particulate matter below apredetermined threshold remains with the filtered liquid component, themethod comprising collecting a sample of saliva, and characterised bypooling the collected sample in a corner region between an upwardlyangled conical or frustoconical first filter surface of the first filterelement and a wall.
 14. The method of filtering according to claim 13,the method performed using the filter assembly provided in a container,the method comprising arranging the container to rest on a level surfacewith the first filter surface as an upwardly angled first filtersurface, and/or the wall extending generally upwards vertically.